With Congress watching whether enough experts are on advisory committees for orphan drugs, the US FDA may be pressured into changes.
Congress is not ready to force the US Food and Drug Administration to designate rare disease expertise for relevant advisory committee meetings, but lawmakers now seem to be paying closer attention to advocates’ long-time complaints about the issue, which could increase the pressure on the agency to make changes.
A provision tucked into the explanatory statement attached to the fiscal year 2023 federal spending package “encourages the...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
